PMA P050038S011
- Device
- ARISTA AH ABSORBABLE HEMOSTAT
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S011
- Product code
- LMG
- Decision date
- 2012-03-23
- Classification
- Agent, Absorbable Hemostatic, Non-collagen Based
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- ADDITION OF AN ALTERNATE SUPPLIER OF A CRITICAL COMPONENT USED IN THE MANUFACTURE OF THE ARISTA AH ABSORBABLE HEMOSTAT.
Current openFDA PMA Record#
- Device
- ARISTA AH ABSORBABLE HEMOSTAT
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S011
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2012-03-23
- Decision code
- OK30
- Date received
- 2012-02-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN ALTERNATE SUPPLIER OF A CRITICAL COMPONENT USED IN THE MANUFACTURE OF THE ARISTA AH ABSORBABLE HEMOSTAT.